Food, Supplement Health Claim Oversight Shift Urged In House Bill
This article was originally published in The Tan Sheet
Executive Summary
FDA's authority to approve health claims for foods and dietary supplements would be removed under a bill introduced in the House Feb. 27 by Rep. Ron Paul (R-Texas)
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FDA's authority to approve health claims for foods and dietary supplements would be removed under a bill introduced in the House Feb. 27 by Rep. Ron Paul (R-Texas). HR 3811, entitled the "Health Information Independence Act of 2002," would amend the FD&C Act by shifting health claim oversight from FDA to an independent review board comprised of scientific experts randomly chosen by the HHS secretary. "To ensure that health claims are evaluated rationally, fairly and in compliance with constitutional requirements...jurisdiction...must be removed from [FDA] and placed in the hands of independent scientific reviewers who do not harbor a bias against food and dietary supplement health claims," the bill states. The legislation contends independent reviewers are needed because FDA has harbored a "strong and unscientific bias against" health claims and has acted "to suppress nutrient-disease information...in direct violation of the constitutional mandates of federal courts and the intent of Congress." The bill language reflects Rep. Paul's longstanding disapproval of agency policy. Paul previously has suggested FDA be prohibited from participating in the Codex harmonization process for foods and supplements; he also has co-signed multiple letters calling for more rapid implementation of the Pearson v. Shalala decision (1 (Also see "FDA Codex Participation Prohibited, Reps. Paul, DeFazio Maintain" - Pink Sheet, 25 Jun, 2001.), p. 10). Under HR 3811, "every health claim [must] be recommended for approval that is supported by credible scientific evidence." If an independent reviewer deems the science supporting the claim "less than conclusive, suggestive but not conclusive, preliminary and inconclusive, or generally accepted but not yet proven to a conclusive degree," then they should recommend the health claim be approved with a "concise disclaimer," the bill says. Disclaimers should be "carefully worded to render the claim nonmisleading," the measure continues. In a floor statement accompanying the legislation, Paul noted acceptable disclaimers could be "a simple statement to the effect that 'scientific studies on these claims are inconclusive' and/or 'these claims are not approved by the FDA.'" Only if a reviewer finds that no credible scientific evidence supports the health claim and that "no disclaimer can eliminate a misleading connotation conveyed by the claim," should they recommend the health claim not be approved, the bill notes. The reviewers would be recruited by FDA within 30 days of the bill's enactment, and every 180 days thereafter, by sending "to every department of medicine, biochemistry, epidemiology, pharmacology, pharmacognosy and nutrition" at accredited universities, "a notice and invitation to participate...in assessing health claims filed with" the agency. Reviewers would hold either a PhD or MD, and be employed full-time "for at least the past five consecutive years as a professor or assistant or associate professor," the bill stipulates. Previous employment at FDA, any other HHS institution or with a body affiliated with the petitioner would be prohibited. Qualified scientists would be randomly selected by the HHS secretary within 15 days of the health claim's filing and evaluations would be completed "within 180 days of receipt of a health claim petition," the measure notes. Within 30 days of receiving the reviewer's determination, HHS should "make the evaluation and all scientific evidence reviewed publicly available" and "publish in the Federal Register as a final and binding order" the recommendation, "verbatim and without any alteration in content whatsoever," the bill states. As compensation, HHS would pay each independent scientific reviewer $40,000 no later than 60 days after receiving their evaluation. Moreover, since the agency would no longer be reviewing the petitions, the legislation recommends FDA "eliminate staff, reduce operating expenses and maximize cost savings...to offset the costs of implementing this Act." HR 3811 has been referred to the House Commerce Committee. No companion legislation has been introduced in the Senate and the bill has no cosponsors. |